Non-inferiority of hybrid outpatient telerehabilitation: 3-month follow-up of a randomized controlled trial.

BACKGROUND: International studies identified comparable or better effects for telerehabilitation compared with face-to-face rehabilitation or no rehabilitation in people with back pain. In German rehabilitation centers, a standardized back school for patients with back pain is provided usually face-to-face as part of a multimodal rehabilitation program. AIM: To examine the non-inferiority of a three-week, digitally assisted, multimodal rehabilitation that applies a digital version of a standardized back school (intervention group [IG]) against the same rehabilitation program applying the back school face-to-face (control group [CG]). DESIGN: Our study was a non-blinded multicenter randomized controlled trial. Recruitment was conducted from 2022 to 2023. We analyzed outcomes at the end of rehabilitation and 3 months later. SETTING: Implementation of the study and enrollment of participants was conducted in 8 German outpatient rehabilitation centers. POPULATION: Rehabilitants aged 18-65 years with back pain were included. METHODS: 284 patients with back pain were randomized into the IG or CG using computer-generated block randomization. We excluded 14 patients as they withdrew their consent and requested removal of their data. We finally included 270 patients (IG: N.=127, CG: N.=143). The primary outcome was self-reported pain self-efficacy (10-60 points). Secondary outcomes were, amongst others, current health status and pain. RESULTS: Our primary adjusted intention-to-treat analysis demonstrated that hybrid digitally assisted rehabilitation was non-inferior to face-to-face rehabilitation at the end of rehabilitation (b=-0.55; 95% CI=-2.75 to ∞) and at the 3-month follow-up (b=0.24; 95% CI=-2.86 to ∞). These results were in line with a non-adjusted intention-to-treat analysis, an adjusted complete case analysis, and an adjusted per-protocol analysis. Secondary outcomes were tested for superiority. Our primary adjusted intention-to-treat analysis found no significant group differences in the secondary outcomes. CONCLUSIONS: This study provides evidence that hybrid digitally assisted rehabilitation in patients with back pain is a sound alternative to face-to-face rehabilitation in an outpatient rehabilitation setting. CLINICAL REHABILITATION IMPACT: Hybrid digitally assisted rehabilitation can improve flexibility and access to rehabilitation. Further studies should examine which components and which time frame of rehabilitation can be digitized without any loss of effectiveness.

Non-inferiority of a hybrid outpatient rehabilitation: a randomized controlled trial (HIRE, DRKS00028770).

Background: Physiotherapeutic telerehabilitation in various musculoskeletal and internal diseases, including back pain, might be comparable to face-to-face rehabilitation or better than non-rehabilitation. In Germany, a standardized back school for patients with chronic back pain is provided in outpatient rehabilitation centers. The effectiveness of this standardized back school was shown in a randomized controlled trial in face-to-face rehabilitation. This study examines non-inferiority of a hybrid rehabilitation applying a digital version of the standardized back school against a rehabilitation applying the face-to-face back school. Methods/design: We recruit 320 patients in eight German outpatient rehabilitation centers. Patients are randomized equally to the intervention and control groups. Patients aged 18 to 65 years with back pain are included. Patients lacking a suitable private electronic device and German language skills are excluded. Both groups receive the standardized back school as part of the 3-week rehabilitation program. The control group receives the back school conventionally in face-to-face meetings within the outpatient rehabilitation center. The intervention group receives the back school online using a private electronic device. Besides the back school, the patients participate in rehabilitation programs according to the German rehabilitation guideline for patients with chronic back pain. Hence, the term "hybrid" rehabilitation for the intervention group is used. The back school consists of seven modules. We assess data at four time points: start of rehabilitation, end of rehabilitation, 3 months after the end of rehabilitation and, 12 months after the end of rehabilitation. The primary outcome is pain self-efficacy. Secondary outcomes are, amongst others, motivational self-efficacy, cognitive and behavioral pain management, and disorder and treatment knowledge. Guided interviews with patients, physicians, physiotherapists and other health experts supplement our study with qualitative data. Discussion/aim: Our randomized controlled trial aims to demonstrate non-inferiority of the online back school, compared to conventional implementation of the back school. Trial registration: German Clinical Trials Register (DRKS00028770, April 05, 2022). Supplementary Information: The online version contains supplementary material available at 10.1186/s44247-023-00013-4.

Feasibility of a 12-Month Exercise Intervention in Postsurgical Colorectal Cancer Patients.

Background: Extensive physical activity (PA; ≥18 MET∗h/week, MET metabolic equivalent of tasks hours) postcancer diagnosis has shown favorable effects on colorectal cancer disease-free survival. However, the feasibility of introducing this high volume of PA in this patient group is unclear. Therefore, the aim of the F-PROTECT study was to evaluate the feasibility of extensive and prolonged PA (≥18 MET∗h/week over 12 months) in colorectal cancer patients with the primary objectives to (1) recruit 50 patients within 12 months and (2) reach an attendance rate of ≥70%. Methods: Single-armed, bicentric, prospective intervention study in colorectal cancer patients (≤80 years; UICC II/III Union for International Cancer Control) after histopathological confirmed R0-resection who were consecutively recruited from visceral surgery units of 10 clinics in Germany. Recruitment rates were calculated using screening logs. Intervention was a 12-month endurance-focused exercise program with supervised and home-based training. Attendance rates defined as ≥70% participation in training sessions were calculated by training diaries. Results: Out of 521 patients who were screened for eligibility, 50 (23 female; 59 ± 10 years, UICC 44% II, 56% III; adjuvant chemotherapy 60%) were recruited within 15 months. Mean duration between surgery and first training was 103 ± 57 days. Training attendance rate was 64% (including 9 dropouts). Six (12%) participants reached ≥18 MET∗h/week in ≥70% of training sessions between 4-12 months. 28 adverse events (n = 9 serious) occurred, however, were not assessed as training related. Conclusions: The present intervention involving a combination of supervised and home-based exercise training in postsurgical colorectal cancer patients was not feasible. Strategies specifically designed for this patient group must be developed and investigated to motivate long-term PA. Registration. The study was prospectively registered at clinicaltrials.gov (NCT01991847).

Effects of virtual reality-based neck-specific sensorimotor training in patients with chronic neck pain: A randomized controlled pilot trial.

OBJECTIVE: To evaluate the effects of neck-specific sensorimotor training using a virtual reality device compared with 2 standard rehabilitation programmes: with, and without general sensorimotor training, in patients with non-traumatic chronic neck pain. DESIGN: Pilot randomized control study. PATIENTS AND METHODS: A total of 51 participants were randomly assigned to 1 of 3 groups: 1: control group; 2: sensorimotor group; 3: virtual reality group. All 3 groups received the clinic's standard rehabilitation programme. Group 2 also received "general sensori-motor training" in the form of group therapy, for a total of 120 min. Group 3 received additional virtual reality-based "neck-specific sensorimotor training" for a total of 120 min. Participants' neck pain, head-aches, active cervical range of motion, and Neck Disability Index were determined before and after 3 weeks of intervention. RESULTS: Compared with the control group, the virtual reality group showed significant (p < 0.05) advantages in relief of headaches, and active cervical range of motion in flexion and extension. Com-pared with the sensorimotor group, the virtual reality group showed significant improvements in cervical extension. CONCLUSION: Virtual reality-based sensorimotor training may increase the effects of a standard rehabilitation programme for patients with non-traumatic chronic neck pain, especially active cervical range of motion in extension.

Interval Endurance and Resistance Training as Part of a Community-Based Secondary Prevention Program for Patients With Diabetes Mellitus and Coronary Artery Disease.

PURPOSE: High-intensity interval training (HIIT) has been observed to improve health and fitness in patients with cardiovascular disease. High-intensity interval training may not be appropriate in community-based settings. Moderate-intensity interval training (MIIT) and resistance training (RT) are emerging as effective alternatives to HIIT. These have not been well investigated in a community-based cardiac maintenance program. METHODS: Patients with coronary artery disease and/or diabetes mellitus participated in clinical examinations and a 6-mo exercise program. Center-based MIIT and home-based moderate continuous intensity exercise were performed for 3-5 d/wk for 30-40 min/session. RT, nutritional counseling, coping, and behavioral change strategies were offered to all patients. Within-group changes in clinical metrics and exercise performance were assessed on a per-protocol basis after 6 mo. RESULTS: Two hundred ninety-two patients (74%) concluded the 6-mo program. There were no serious adverse events. The peak oxygen uptake and peak workload increased significantly, 21.8 ± 6.1 to 22.8 ± 6.3 mL/kg/min and 128 ± 39 to 138 ± 43 W, respectively (both P < .001). Submaximal exercise performance increased from 68 ± 19 to 73 ± 22 W (P < .001). Glycated hemoglobin decreased from 6.57 ± 0.93% to 6.43 ± 0.12%, (P = .023). Daily injected insulin dosage was reduced from 42 IU (interquartile range: 19.0, 60.0) to 26 IU (interquartile range: 0, 40.3, P < .001). CONCLUSIONS: MIIT and RT were feasible and effective in a community-based cardiac maintenance program for patients with cardiovascular disease, improving exercise performance, and blood glucose control.

Work-related rehabilitation aftercare for patients with musculoskeletal disorders: results of a randomized-controlled multicenter trial.

There is evidence that rehabilitation with a multidisciplinary focus on work-related demands effectively improves work ability and quickens return to work in patients with musculoskeletal disorders. There could be benefits to the transfer of work-related components into rehabilitation aftercare. We examined the effectiveness of an intensified work-related rehabilitation aftercare program compared with standard intensified rehabilitation aftercare in Germany on work ability. We randomly assigned 307 patients with musculoskeletal disorders from 11 rehabilitation centers to an aftercare program with work-related functional capacity training, work-related psychosocial groups, social counseling, relaxation training and exercise therapy (intervention group), or the usual aftercare program consisting of only exercise therapy (control group). The 6-month follow-up questionnaire was completed by 78.5% of patients. There was no statistically relevant between-group difference in follow-up primary (work ability) and secondary outcomes (e.g. health-related quality of life, sick leave duration). Significant improvements were observed within both the intervention and the control groups. Severely disabled participants in the intervention group had better physical functioning and shorter sick leave duration after 6 months compared with severely disabled patients in the control group. A partial replacement of standard exercise therapy by a more work-related therapy does not seem to improve work ability superiorly. Improved aftercare treatment may require a focus on employer participation and involvement within the actual work environment.